MAUDE Adverse Event Report: ALLERGAN (PRINGY) VOLBELLA WITH LIDOCAINE; IMPLANT, DERMAL, FOR AESTHETIC USE

Catalog Number 94731RX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Foreign Body Reaction (1868); Inflammation (1932); Skin Discoloration (2074)

Event Date 04/15/2019

Event Type  Injury  

Manufacturer Narrative

Further information regarding event, product, or patient details has been requested.No additional information is available at this time.The events are physiological complications and analysis of the device generally does not assist allergan in determining a probable cause for these events.A review of the device history record has been initiated.If any deviations or non-conformance's are found, a supplemental medwatch will be submitted.This is a known potential adverse event addressed in the product labeling.

Event Description

Patient reports that injections with 1 ml juvederm® volbella¿ with lidocaine to the corner of mouth (both sides, upper left lip) and 1 ml juvéderm¿ voluma¿ with lidocaine to the nose wing ¿caused a super problem." 2 months post injection, deformation noted.Huge nodes appeared in the region injected with juvederm® volbella¿ with lidocaine."surgical removal" performed one month post symptom apparition.3 days later an anatomopathological was performed noting a "foreign body reaction" of the mucosa of the cheek/left side.12 days later a biopsy was completed confirming the diagnosis.Triancil was applied directly to the lesion 6 days later.Symptoms are ongoing.The nodules are smaller, but they exist.This is the same event and the same patient reported under mdr id# 3005113652-2019-00511 ((b)(4)). this mdr is being submitted for the first suspect product, juvederm® volbella¿.

• Brand Name: VOLBELLA WITH LIDOCAINE
• Type of Device: IMPLANT, DERMAL, FOR AESTHETIC USE
• Manufacturer (Section D): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer (Section G): ALLERGAN (PRINGY); route de promery; zone artisanale de pre-mairy; pringy 74370 ; FR 74370
• Manufacturer Contact: michelle burgess ; 301 w howard lane; suite 100; austin, TX 78753 ; 7372473605
• MDR Report Key: 8750131
• MDR Text Key: 149699041
• Report Number: 3005113652-2019-00510
• Device Sequence Number: 1
• Product Code: LMH
• Combination Product (y/n): N
• PMA/PMN Number: P110033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial
• Report Date: 07/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 94731RX
• Device Lot Number: V15LA80287
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/03/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: JUVÉDERM¿ VOLUMA¿ WITH LIDOCAINE
• Patient Age: 36 YR